Immune Design Announces Positive FDA Feedback on Phase 3 Clinical Trial Design for CMB305 in Synovial Sarcoma Patients
October 16 2017 - 4:15PM
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today announced that based on productive
discussions with the U.S. Food and Drug Administration (FDA), it
plans to initiate a pivotal Phase 3 trial to support a Biologics
License Application (BLA) for CMB305, a novel cancer vaccine, in
patients with synovial sarcoma.
The randomized Phase 3 trial will evaluate
CMB305 monotherapy vs. placebo in patients with NY-ESO-1+ locally
advanced unresectable or metastatic synovial sarcoma, a sub type of
soft tissue sarcoma, who have no evidence of progression after
first-line chemotherapy. Immune Design intends to start the study
in mid-2018 and enroll 248 patients aged twelve and older. Patients
will be randomized 1:1 to receive either CMB305 monotherapy or
placebo. The trial will have progression free survival (PFS)
followed by overall survival (OS) as co-primary endpoints. If the
PFS endpoint is successful, the FDA offered that it may support
full approval of CMB305. Depending on the rate of events, final PFS
analysis may occur as early as 24 months from the first patient
dosed.
About Synovial Sarcoma
Soft tissue sarcomas are malignancies that arise
from the soft tissues of the body, such as tissues that connect,
support and surround other body structures including muscle, fat,
blood vessels, nerves, tendons and the lining of joints. Synovial
sarcoma is a sub type of soft tissue sarcoma where 70% of diagnoses
occur in patients under 40 years old, is associated with a high
risk of recurrence, and has been shown to have high expression of
the NY-ESO-1 tumor antigen. The primary treatment for patients with
locally advanced, unresectable or metastatic synovial sarcoma
typically consists of an anthracycline-based chemotherapy regimen
administered alone or in combination with other agents. Following
disease progression after first line systemic therapy, treatment
options are limited and median overall survival rates have been
reported to be approximately 12 months. In
connection with the planned Phase 3 study for CMB305 monotherapy,
the FDA has agreed with Immune Design that synovial sarcoma
patients constitute an unmet medical need.
About CMB305
CMB305 is an investigational prime-boost
vaccine approach against NY-ESO-1-expressing tumors, designed to
generate an integrated, anti-NY-ESO-1 immune response in
vivo via a targeted, specific interaction with dendritic
cells, a mechanism of action Immune Design believes differs from
traditional cancer vaccines. CMB305 is being evaluated in soft
tissue sarcoma patients in ongoing Phase 1 monotherapy and Phase 2
combination studies. Immune Design has received Orphan Drug
Designation for CMB305 from the FDA for the treatment of soft
tissue sarcoma, as well as from the FDA and European Commission for
each of the components of CMB305 for the treatment of soft tissue
sarcoma.
Conference Call Information
Immune Design will host a conference call and
live audio webcast tomorrow, October 17, at 5:30 a.m. Pacific
time / 8:30 a.m. Eastern time to discuss the CMB305 development
strategy and pivotal trial design.
To participate in the conference call, please
dial 844-266-9538 for domestic callers and 216-562-0391 for
international callers and provide the conference ID 9299539, or
access the listen-only live webcast by visiting the investor
relations section of the company website at
http://ir.immunedesign.com/events.cfm.
A telephone replay of the call will be available
for five days by dialing 855-859-2056 for domestic callers or
404-537-3406 for international callers and entering the conference
code: 9299539. An archived copy of the webcast will be available on
Immune Design's website beginning approximately two hours after the
conference call and will be available for at least 30 days after
the conference call.
About Immune Design
Immune Design is a clinical-stage immunotherapy
company employing next-generation in vivo approaches to enable the
body's immune system to fight disease. The company's technologies
are engineered to activate the immune system's natural ability to
generate and/or expand antigen-specific cytotoxic T cells, while
also enhancing other immune effectors, to fight cancer and other
chronic diseases. CMB305 and G100, the two leading product
candidates focused in cancer immunotherapy, are the first products
from Immune Design’s two separate discovery platforms targeting
dendritic cells in vivo, ZVex® and GLAAS®. Both ZVex and
GLAAS also have potential applications in infectious disease and
allergy as demonstrated by ongoing pharmaceutical
collaborations. Immune Design has offices in Seattle and
South San Francisco. For more information, please visit
www.immunedesign.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995. Words such as
"may," "will," "expect," "plan," "anticipate," "estimate," "intend"
and similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These
forward-looking statements are based on Immune
Design's expectations and assumptions as of the date of this
press release. Each of these forward-looking statements involves
risks and uncertainties that could cause our clinical development
programs, future results or performance to differ significantly
from those expressed or implied by the forward-looking statements.
Forward-looking statements contained in this press release include,
but are not limited to, statements about the design, progress,
timing, scope and potential results of the pivotal Phase 3 clinical
trial of CMB305 in synovial sarcoma patients, the possibility that
PFS data will be sufficient to support regulatory approval and the
timing of the PFS analysis. Many factors may cause differences
between current expectations and actual results including
unexpected safety or efficacy data, clinical trial site activation
or enrollment rates that are slower than expected, changes in
expected or existing competition, changes in the regulatory
environment, the uncertainties and timing of the regulatory
approval process and unexpected litigation or other disputes. Other
factors that may cause Immune Design's actual results to
differ from those expressed or implied in the forward-looking
statements in this press release are discussed in Immune
Design's filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained
therein. Except as required by law, Immune Design assumes
no obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Media ContactJulie RathbunRathbun
Communicationsjulie@rathbuncomm.com
206-769-9219
Investor ContactShari
AnnesAnnes Associatessannes@annesassociates.com650-888-0902
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